A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: Faster-acting insulin aspart; Drug: Insulin Aspart

• Registration Number: NCT02933853
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects with Type 2 Diabetes Mellitus

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-13
• Study Start: 2016-10-14
• Study First Posted: 2016-10-14
• Primary Completion: 2017-12-21
• Study Completion: 2017-12-21
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-22
• Last Update Posted: 2019-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. The total number of subjects aged 65-75 years (both inclusive) must NOT exceed 25.
• Subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months (365 days) prior to the day of screening
• HbA1C below or equal to 9.5 % based on central laboratory analysis

Exclusion Criteria

• Smoker (defined as a subject who is smoking more than one cigarette or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period
• Surgery or trauma with significant blood loss (more than 500 mL) within the last 90 days prior to screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Faster Aspart	Faster-acting insulin aspart	-
Insulin Aspart	Insulin Aspart	-

Primary Outcome Measures

Name	Time	Method
Area under the serum insulin aspart concentration-time curve	From 0 to 30 minutes

Secondary Outcome Measures

Name	Time	Method
Maximum glucose infusion rate	Within 0 to 12 hours after dosing
Maximum observed serum insulin aspart concentration	Within 0 to 12 hours after dosing
Area under the glucose infusion rate curve	From 0 to t, where t is the last time where glucose infusion rate (GIR) exceeds zero (within 0 to 12 hours after dosing)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇹 Graz, Austria